(198 days)
No
The device description and performance studies focus on the mechanical and material properties of the infusion sets and needles, with no mention of AI or ML.
No.
The device is an infusion set and needle set used to access an implanted port for infusing fluids and drugs, blood sampling, and in some cases, power injection of contrast media. It is a delivery/access device, not a device that itself provides therapy.
No
The device is used for infusing fluids, drugs, blood sampling, and power injection of contrast media, which are therapeutic and procedural activities, not diagnostic tests. The performance studies focus on the device's physical integrity and functional aspects related to these procedures.
No
The device description clearly outlines physical components like needles, infusion sets, and safety mechanisms, indicating it is a hardware medical device.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of both the PowerLoc™ Max Power Injectable Infusion Set and the SafeStep™ Huber Needle Set is for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. They are used to deliver substances into the body or withdraw blood from the body.
- Device Description: The descriptions reinforce this by detailing their function in accessing implanted ports for infusion and blood sampling.
- Lack of Diagnostic Purpose: There is no mention of these devices being used to examine specimens in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVDs are typically used to test samples like blood, urine, or tissue in a laboratory setting to detect or measure specific substances or characteristics. These devices are used for direct interaction with the patient's vascular system for therapeutic or sampling purposes.
N/A
Intended Use / Indications for Use
PowerLoc™ Max Power Injectable Infusion Set:
The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.
For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.
SafeStep™ Huber Needle Set:
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
Product codes (comma separated list FDA assigned to the subject device)
PTI
Device Description
PowerLoc™ Max Power Injectable Infusion Set
PowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non-pyrogenic, for single use only.
The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site.
SafeStep™ Huber Needle Set
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The site of a surgically implanted vascular port.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests were conducted by or for Bard Access Systems (BD) per guidance documents and standards in conjunction with in-house protocols to establish the performance of the PowerLoc™ Max Power Injectable Infusion Set and SafeStep™ Huber Needle Set, and in determining substantial equivalence to the predicate K171735. All testing passed the predetermined acceptance criteria.
- Biocompatibility Testing: Tests to confirm that the catheter is free from biological hazard per testing. A health-based risk assessment per ISO 10993-1 was performed for determining the acceptability of the material for the intended purpose. Testing Performed includes: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Subchronic Systemic Toxicity, Hemocompatibility (Reference Standard: ISO 10993-1:2009).
- Assembly Burst: Burst pressure test to confirm the assembly burst pressure exceeds the peak pressure at maximum flow conditions. (Reference Standard: ISO 10555-1:2013).
- Assembly Tensile: Test to demonstrate the peak tensile force of each assembly exceeds the minimum peak tensile force. (Reference Standard: ISO 8536-4:2019).
- Assembly Air Leak: Test to confirm that the assembly will not leak when occluded. (Reference Standard: ISO 8536-10:2015).
- Assembly High Pressure Water Leak/Burst (2X): Test to confirm the PowerLoc™ Max Power Injectable Infusion Set does not leak or burst at maximum indicated flow rate. (Reference Standard: ISO 8536-10:2015).
- Assembly Occlusion/Flow Rate: Test to confirm minimum flow rates. (Reference Standard: ISO 7864:2016).
- Clamp Function: Test to confirm that fluids will not pass through tubing when the clamp is engaged. (Internal Standard).
- Luer Adapter Testing: Testing to ensure that Luer adapters meet requirements for: Leak, Leak Decay, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding (Reference Standard: ISO 80369-7).
- Particulate Testing: Testing to ensure that particulate matter on the catheter post-manufacture is not exceeded for prescribed particle sizes. (Reference Standard: USP).
- Needleless Y-Site Testing: Testing to ensure needleless access connector used in SafeStep™ Huber Needle Set configurations with Y-site meet requirements for: Microbial Ingress, Valve Activation, Air Introduction Due to Device Connect/Disconnect (Reference Standard: Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)] (Document Issued July 11, 2008)).
- Residual Toxicity: Testing to ensure EO residuals are below requirements for any patient with an implanted port. (Reference Standard: ISO 10993-7:2008).
- Clinical Testing: Clinical data was not needed to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2024
Bard Access Systems, Inc. Catherine Langford Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K241353
Trade/Device Name: PowerLoc™ Max Power Injectable Infusion Set: SafeStep™ Huber Needle Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: October 28, 2024 Received: October 28, 2024
Dear Catherine Langford:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Porsche Bennett
Porsche Bennett for David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241353
Device Name
PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set
Indications for Use (Describe)
PowerLocTM Max Power Injectable Infusion Set:
The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.
For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.
SafeStep™ Huber Needle Set:
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| £ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
| Contact
Details
21 CFR
| 807.92(a)(1) | Submitter Name: | Bard Access Systems, Inc. |
|---|---|---|
| Submitter Address: | 605 North 5600 West | |
| Salt Lake City, Utah 84116 USA | ||
| Contact Telephone: | 801.522.5000 | |
| Contact Person: | Catherine Langford | |
| Regulatory Affairs Specialist | ||
| Contact Email | catherine.langford@bd.com | |
| Date of Preparation: | 27 November 2024 | |
| Device Name | ||
| 21 CFR | ||
| 807.92(a)(2) | Trade Name: | PowerLoc™ Max Power Injectable Infusion Set; |
| SafeStep™ Huber Needle Set | ||
| Common Name: | Hypodermic single lumen needle | |
| Classification Name: | Non-Coring (Huber) Needle | |
| Class: | Class II | |
| Regulation Number: | 880.5570 | |
| Product Code: | PTI | |
| Classification Panel: | General Hospital | |
| Predicate | ||
| Device | ||
| 21 CFR | ||
| 807.92(a)(3) | Trade Name: | PowerLoc® MAX Power-Injectable Infusion Set; |
| SafeStep® Huber Needle Set | ||
| Common Name | Hypodermic single lumen needle | |
| Classification Name: | Non-Coring (Huber) Needle | |
| Class: | Class II | |
| Regulation Number: | 880.5570 | |
| Product Code: | PTI | |
| Premarket Notification | ||
| Number: | K171735 |
K241353 - 510(k) Summary 21 CFR 807.92(a)
PowerLoc™ Max Power Injectable Infusion Set:
The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.
Indications for Use 21 CFR 807.92(a)(5)
For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.
SafeStep™ Huber Needle Set:
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
5
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
| Device
Description
21 CFR
807.92(a)(4) | PowerLoc™ Max Power Injectable Infusion Set
PowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non- pyrogenic, for single use only.
The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site.
SafeStep™ Huber Needle Set
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection. |
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Image /page/5/Picture/4 description: The image shows a diagram of the Subject PowerLoc Max Power Injectable Infusion Set (19 GA with Y-site shown). The diagram includes labels for the different parts of the infusion set, such as the female locking luer connection, safety guard handle, administration tubing, adaptable Y-site female locking luer connection, Huber needle, pinch clamps, and non-vented male luer caps. The safety guard base includes the inner base, sleeve, shutter, and comfort pad.
6
Image /page/6/Figure/1 description: The image shows a SafeStep Huber Needle Set (19 GA with needleless Y-site shown). The different parts of the needle set are labeled, including the needleless access connector Y-site, pinch clamps, administration tubing, female locking luer connection, Huber needle, safety guard base, non-vented male luer cap, and safety guard handle. The image also includes text describing the indications for use and comparison of the Huber Needle Set. The text states that the intended use has not changed compared to the predicate.
7
| | Component | SUBJECT DEVICE
PowerLoc™ Max Power
Injectable Infusion Set
SafeStep™ Huber Needle Set | PREDICATE DEVICE (K171735)
PowerLoc™ Max Power
Injectable Infusion Set
SafeStep™ Huber Needle Set |
|--|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | Huber Needle | Same as predicate | Stainless Steel |
| | Adhesive | Same as predicate | UV Cured Acrylic |
| | Needle Lubricant | Silicone | Silicone |
| | Needle Cover | Same as predicate | Polyethylene |
| | Safety Guard Base | Same as predicate | Styrene-Butadiene Copolymer or
Polycarbonate |
| | Safety Guard
Inner Based | Same as predicate | Styrene-Butadiene Copolymer +
Colorant
19GA (Yellow)
20GA (Brown)
22GA (Black) |
| | Safety Guard
Sleeve | Same as predicate | Stainless steel |
| | Safety Guard
Shutter | Same as predicate | Stainless steel |
| | Safety Guard
Handle | Same as predicate | Styrene-Butadiene Copolymer |
| | Safety Guard
Comfort Pad | Same as predicate | Polyethylene |
| | Administration
Tubing | Thermoplastic polyurethane | Polyvinyl chloride |
| | Female Locking
Luer Connection | Polyvinyl chloride (Type of PVC and
dimension) | Polyvinyl chloride |
| | Adaptable Y-
Injection site
Female Locking
Luer Connection | Same as predicate | Polyvinyl chloride |
| | Non-vented Male
Luer Cap | Same as predicate | Acrylonitrile butadiene styrene +
White Colorant |
| | Pinch Clamp | Acetal (polyoxymethylene) +
Colorant
19G: Brown
20G: Yellow
22G: Black | Polypropylene + Colorant
19G: Brown
20G: Yellow
22G: Black |
| | Pinch Clamp Ink
(PowerLoc™ Max
Power Injectable
Infusion Set
ONLY) | White Ink
Black Ink | White Ink
Black Ink |
| | Needless Access
Connector Y-Site | Same as predicate | Polycarbonate |
Technological
Comparisonison
8
.
| (SafeStep™ Huber
| Needle Set ONLY) | ||
|---|---|---|
| Needless Access | ||
| Connector Y-Site | ||
| Valve (SafeStep™ | ||
| Huber Needle Set | ||
| ONLY) | Same as predicate | Silicone |
| Fundamental | ||
| Scientific | ||
| Technology | Same as predicate | The device accesses implanted |
| ports to transport fluid into and | ||
| out of the central venous system. | ||
| It utilizes a standard right angle | ||
| non-coring Huber needle and | ||
| administration set with a | ||
| needlestick prevention feature. | ||
| Device Sizes | ||
| and Tubing | ||
| Dimensions | Same as predicate | Needle Gauge - 19G, 20G or 22G |
| Needle Length - 0.75 in., 1.00 in., | ||
| 1.50 in. | ||
| Clamp Color Guided by ISO 6009 - | ||
| 19G Brown, 20G Yellow, | ||
| 22G Black | ||
| Tubing dimension with needleless | ||
| Y-site - 4.00 in | ||
| Tubing dimension without | ||
| needleless Y-site - 8.00 in | ||
| Product | ||
| Configurations | Same as predicate | Standalone and convenience kit |
| Sterilization | ||
| Modality | Ethylene Oxide | Ethylene Oxide |
| Minimum SAL | Same as predicate | 1 x 10-6 |
| Anatomical Site | ||
| Use | Same as predicate | The site of a surgically implanted |
| vascular port. | ||
| Disposable or | ||
| Reusable | Same as predicate | Disposable - Single-use device |
| Safety Infusion | ||
| Set Device | ||
| Components | End Cap | |
| Luer Connector | ||
| Tubing | ||
| Non-Winged Grip | ||
| Safety Guard Base | ||
| Pinch Clamps | ||
| Needle | ||
| Needle Handle | End Cap | |
| Luer Connector | ||
| Tubing | ||
| Non-Winged Grip | ||
| Safety Guard Base | ||
| Pinch Clamps | ||
| Needle | ||
| Needle Handle |
9
| | Subject Device
PowerLoc™ Max Power Injectable
Infusion Set | Predicate Device (K171735)
PowerLoc™ Max Power Injectable
Infusion Set |
|--------------|------------------------------------------------------------------|------------------------------------------------------------------------------|
| Gauge
(G) | Power Injector Flow Rate at 11.8 cPs
at 325 psi (2241 kPa) | Power Injector Flow Rate at 11.8 cPs
at 325 psi (2241 kPa) |
| 19 | Same as predicate | 5 mL/s |
| 20 | Same as predicate | 5 mL/s |
| 22 | Same as predicate | 2 mL/s |
| | Subject Device
PowerLoc™ Max
Power Injectable
Infusion Set
SafeStep™ Huber
Needle Set | Predicate Device (K171735)
PowerLoc™ Max Power Injectable Infusion Set
SafeStep™ Huber Needle Set | |
|------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Priming
Volume (on
labeling) | Same as predicate | Without Y-site | 0.3 mL |
| | | SafeStep™ with
needleless Y-site | 0.7 mL |
| | | PowerLoc™ Max with
Y-site | 0.4 mL |
| Residual
Volume | Same as predicate | SafeStep™ with
needleless Y-site | : Sizing and Counting Particulate Matter | | |
| Particulate
Testing | Testing to ensure that particulate matter on the catheter post-manufacture is not exceeded for prescribed particle sizes. | |
| Reference Standard: Guidance for Industry and FDA Staff: Intravascular Administration Sets
Premarket Notification Submissions [510(k)] (Document Issued July 11, 2008) | | |
| Needleless Y-
Site Testing | Testing to ensure needleless access connector used in SafeStep™ Huber
Needle Set configurations with Y-site meet requirements for:
• Microbial Ingress
• Valve Activation
• Air Introduction Due to Device Connect/Disconnect | |
| Reference Standard: ISO 10993-7:2008: Biological evaluation of medical devices - Part 7: Ethylene
oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1:
Applicability of allowable limits for neonates and infants (2019)] | | |
| Residual Toxicity | Testing to ensure EO residuals are below requirements for any patient with an implanted port. | |
| Clinical Testing | Clinical data was not needed to demonstrate substantial equivalence. | |
| Technological
Comparison to
Predicate
Device | The subject PowerLoc™ Max Power Injectable Infusion Set and SafeStep™ Huber
Needle Set has the same intended use and fundamental technological characteristics
as the cited predicate device cleared under K171735. The tubing and clamp
materials differ from the predicate device; however, this difference does not alter the
intended use of the subject device and does not raise any new or different questions
regarding safety or effectiveness when compared to the predicate device. | |
| Summary of
Substantial
Equivalence | Based on the intended use, technological characteristics, and results of performance
testing, the subject PowerLoc™ Max Power Injectable Infusion Set and SafeStep™
Huber Needle Set is considered substantially equivalent to the cited predicate device. | |
11